The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.

Device Description

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors. 2. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.

AI/ML Overview

Let's break down the acceptance criteria and the supporting study for the QiF Blood and Fluid Warmer based on the provided 510(k) summary.

Key takeaway: This 510(k) submission is primarily focused on changing a contraindication to a precaution statement regarding plasma warming. The performance study is to demonstrate that the device still warms plasma to the specified temperature, thus maintaining equivalent performance to the predicate device. It is not a complex AI/imaging system.

Here's the information extracted and organized:

Acceptance Criteria and Reported Device Performance

Given that this is a medical device for warming fluids, the primary performance criterion is the ability to warm the fluid to a specified temperature.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Device set point temperature	Plasma warmed to 38 ± 2 °C (98.6 ± 3.6 °F)
Device function as intended	Device functioned as intended in all instances
Equivalent performance to predicate	Demonstrated equivalent performance to its predicate device

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not specify a numerical sample size for the performance tests. It broadly states that "Performance tests were performed."
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies an experimental setup to test fluid warming.

3. Number of Experts and Qualifications for Ground Truth:

Not Applicable: This is a physical device warming a fluid to a specific temperature. The "ground truth" is established by direct temperature measurement using calibrated equipment, not by expert interpretation. There are no human experts involved in establishing this "ground truth."

4. Adjudication Method for the Test Set:

Not Applicable: As there are no expert interpretations or subjective assessments involved, no adjudication method is necessary. The performance is measured objectively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No: This is not an imaging device or an AI assistant for human readers. Therefore, an MRMC study is not relevant or performed.

6. Standalone Performance (Algorithm Only):

Yes (in concept, but not an "algorithm" as typically defined for AI): The device's primary function is to warm fluid to a set temperature. The performance study measures the device's ability to achieve this independent of human interaction (beyond initial setup and monitoring). The "algorithm" here would be the internal control system ensuring the desired temperature. The study directly assesses the device's own output temperature against the set point.

7. Type of Ground Truth Used:

Objective Measurement/Physical Standard: The ground truth is the precise measurement of the warmed plasma's temperature, verified against the engineering specification of 38 ± 2 °C. This is a direct physical measurement.

8. Sample Size for the Training Set:

Not Applicable: This is a hardware device with firmware, not a machine learning model that requires a "training set" in the common sense of data for a learning algorithm. The device's internal control system would have been developed through engineering design, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As there is no "training set" in the machine learning context, this question is not relevant. The device's operational parameters (like the target temperature and its tolerance) are engineering specifications.

Summary of the study: The study performed was a verification test to ensure that the QiF Blood and Fluid Warmer consistently warms plasma to the specified temperature range (38 ± 2 °C). This was critical because the purpose of the 510(k) was to change a contraindication against plasma warming to a precaution, requiring proof that the warming function itself was adequate for plasma. The document explicitly states: "In all instances, the device functioned as intended and demonstrated equivalent performance."

Summary

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510(k) SUMMARY - K171215 Quality in Flow's QiF Blood and Fluid Warmer

Manufacturer: Quality in Flow Ltd.

Phone: (972) (54) 6600146 Contact Person: Neta Sherman

Date Prepared: September 26, 2017

Subject Device

Name of Device- QiF Blood and Fluid Warmer Common Name- QiF Blood and Fluid Warmer Regulation Number- 21 C.F.R 880.5725 Regulation Name- Infusion pump Regulatory class- class II Product Code LGZ, BSB Classification Panel- General Hospital

Predicate Device

510(k) Number- K163708 Name of Device- QiF Blood and Fluid Warmer Common Name- QiF Blood and Fluid Warmer Regulation Number- 21 C.F.R 880.5725 Requlation Name- Infusion pump Regulatory class- class II Product Code LGZ, BSB Classification Panel- General Hospital

Indications for Use

Description

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer.

The QiF device is composed of the following main components:

1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the

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patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.

1. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW).
1. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.

Purpose of 510(k)

The purpose of this 510(k) is to replace the contraindication against plasma warming with the QiF device with a precaution statement.

Performance Data

Performance tests were performed in order to demonstrate that the device has equivalent performance to its predicate. Specifically, testing was conducted to verify that the QiF device will warm plasma to the device set point temperature (38 ± 2 °C; 98.6±3.6°F).

In all instances, the device functioned as intended and demonstrated equivalent performance. Studies have not been performed to evaluate the effects on clotting factors in plasma products following warming with the QiF Blood and Fluid Warmer.

Technological Characteristics

The QiF Blood and Fluid is not changed, thus it has identical technological characteristics as the predicate QiF Blood and Fluid Warmer.

The QiF Blood and Fluid Warmer is a portable, inline Blood and Fluid Warmer located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The device is comprised of a Base Unit (BU) and a sterile disposable cartridge (Disposable Unit). The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The Base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The DU has a standard intravenous tube extension.

Substantial Equivalence

An SE Table is presented below:

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Conclusions

The QiF Blood and Fluid Warmer is substantially equivalent to the predicate device.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two parts: a circular seal on the left and a symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol on the right features a stylized depiction of three human profiles facing right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2017

Quality In Flow Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004

Re: K171215

Trade/Device Name: QiF Blood and Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: April 25, 2017 Received: April 25, 2017

Dear John Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).

	Quality in Flow – QiFBlood and Fluid Warmermodel 01 [Subject]	Quality in Flow – QiFBlood and Fluid Warmermodel 01 [K163708]	SE Justification
Indications for Use	Intended for warmingblood, blood products, andintravenous fluids prior toadministration. It isintended to be used byhealthcare professionals inhospitals, clinics and fieldenvironments, to helpprevent hypothermia.	Intended for warmingblood, blood products, andintravenous fluids prior toadministration. It isintended to be used byhealthcare professionals inhospital, clinics and fieldenvironments, to helpprevent hypothermia.	Same
Intended use	Medical emergencies orsurgeries where warm fluidadministration is requiredto treat the patient.Whenever parenteralintroduction ofnormothermic fluid aredesired or indicated	Medical emergencies orsurgeries where warm fluidadministration is requiredto treat the patient.Whenever parenteralintroduction ofnormothermic fluid aredesired or indicated	Same
Fluids that Can beWarmed	IV Fluids, Blood, BloodProducts	IV Fluids, Blood, BloodProducts	Same
Components	Warmer with display and asterile, disposable heatexchanger	Warmer with display and asterile, disposable heatexchanger	Same
Safety Features	• System self-test• Overheat notification• Overheat cut-off• Battery under-voltageprotection (cut-off)	• System self-test• Overheat notification• Overheat cut-off• Battery under-voltageprotection (cut-off)	Same
Notification Types	• Overheat• Under heat• Low battery• Flow irregularity	• Overheat• Under heat• Low battery• Flow irregularity	Same
User Interface /Notifications	• Visual (LCD display)and audio• Self-test/mute button• On/off switch	• Visual (LCD display)and audio• Self-test/mute button• On/off switch	Same
Power Source	Rechargeable Battery	Rechargeable Battery	Same
Infusion temp.	$38±2°C$	$38±2°C$	Same
Heating Method	Resistive heating	Resistive heating	Same
	Quality in Flow – QiFBlood and Fluid Warmermodel 01 [Subject]	Quality in Flow – QiFBlood and Fluid Warmermodel 01 [K163708]	SE Justification
Fluid Path	Located within the steriledisposable cartridges(DU).Spiral stainless steel tubeand a short segment of aPVC tubeThe tube serves as theconductor of electricalcurrent.	Located within the steriledisposable cartridges(DU).Spiral stainless steel tubeand a short segment of aPVC tubeThe tube serves as theconductor of electricalcurrent.	Same
Flow Rate	Based on gravity or fluidpump, up to 160 – 180ml/min	Based on gravity or fluidpump, up to 160 – 180ml/min	Same
Software	The software control theheating process and theoperation of the device	The software control theheating process and theoperation of the device	Same
Biocompatibility	The fluid path is made ofbiocompatible StainlessSteel, PVC and luerconnections	The fluid path is made ofbiocompatible StainlessSteel, PVC and luerconnections	Same
Sterility	The disposable unit isprovided sterile for singlepatient use	The disposable unit isprovided sterile for singlepatient use	Same
Single Use or Reusable	Single Use	Single Use	Same
Shelf Life	DU shelf life - 3 years	DU shelf life - 3 years	Same
Storage conditions	-4°F to 140°F & 93% RHand compliance to -22°F to158°F	-4°F to 140°F & 93% RHand compliance to -22°F to158°F	Same
Operating conditions	41°F &15%RH to 104°F &93% RH and compliancewith 23°F to 104°F	41°F &15%RH to 104°F &93% RH and compliancewith 23°F to 104°F	Same
Altitude	-1312 to 15,000ft	-1312 to 15,000 ft	Same
Dimensions of BaseUnit with Battery	Approximately 235x160x75mm (9.25x6.5x2.9 in)	Approximately 235x160x75mm (9.25x6.5x2.9 in)	Same
Dimensions ofDisposable Unit insterile bag	DU:Approximately210x160x45mm(8.3x 6.5x1.8 in)	DU:Approximately210x160x45mm(8.3x 6.5x1.8 in)	Same
Warmer Type	Inline warmer	Inline warmer	Same
	Quality in Flow – QiFBlood and Fluid Warmermodel 01 [Subject]	Quality in Flow – QiFBlood and Fluid Warmermodel 01 [K163708]	SE Justification
Heat Insulation	Yes: the heat exchanger isencased within anexpanded polypropylene(EPP) oval box to preventany contact between theuser and warm tubeintended to providethermal and electricalisolation between thedevice and the user.	Yes: the heat exchanger isencased within anexpanded polypropylene(EPP) oval box to preventany contact between theuser and warm tubeintended to providethermal and electricalisolation between thedevice and the user.	Same